Effective August 2, 2022, mdxhealth has acquired the Oncotype DX Genomic Prostate Score (GPS) test from Exact Sciences. Additionally, Genomic Health Inc, part of Exact Sciences, will continue to perform the GPS test during the transition. Further communications explaining transition plans will be provided in the coming months. For more details, please review the press release.
Questions? Email: gps@mdxhealth.com
Region: United States
Breast Cancer

Clinical Evidence for Node-Positive Patients

It’s never been as clear to identify node-positive patients who can safely be spared chemotherapy.1-7
Clinical Highlights | RxPONDER Trial

The value of Oncotype DX Breast Recurrence Score® test in node-positive patients:

  • The Oncotype DX® test is both prognostic and predictive of chemotherapy benefit in the node-positive population3,7
  • The only multigene assay proven to predict chemotherapy benefit, regardless of nodal status
The 21-gene test has been incorporated into major clinical practice guidelines worldwide, including NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)8-14
  • Preferred for N0 and N1 postmenopausal patients with HR+, HER2-disease, backed by level 1 evidence

    • RxPONDER trial

    The RxPONDER trial prospectively randomized 5083 HR+, HER2-, node-positive patients with Recurrence Score® results 0 to 25 to receive chemotherapy followed by endocrine therapy or endocrine therapy alone. Primary endpoints are to:15

    • Assess the chemotherapy benefit for these patients according to their Recurrence Score result
    • Determine if Recurrence Score results and chemotherapy are independently prognostic

    RxPONDER study design: node-positive (1-3 nodes) patients with Recurrence Score results 0-25 were randomized to endocrine therapy alone or chemoendocrine therapy

    SWOG RxPONDER

    First results from the study, led by the independent SWOG Cancer Research Network, and sponsored by the National Cancer Institute (NCI) indicate:16

    • The majority of HR+, HER2-, N1, postmenopausal patients can be spared chemotherapy when decisions are guided with the Oncotype DX test
    • Postmenopausal women with 1 to 3 positive nodes and Recurrence Score results 0-25 can forgo adjuvant chemotherapy regardless of clinical pathological parameters
    • Premenopausal women with 1 to 3 positive nodes and Recurrence Score results 0-25 modestly benefit from chemotherapy

    Safely spare postmenopausal patients chemotherapy with confidence16

    Postmenopausal women with Recurrence Score result of 0-25 did not show benefit of chemotherapy in addition to endocrine therapy (competing risk-adjusted HR = 1.12, 95% CI 0.82-1.52, P=0.49). Consistent lack of chemotherapy benefit was observed for IDFS for subgroups of age, tumor size, grade, Recurrence Score result, and number of positive lymph nodes.

     

    Determine chemotherapy options for N1 premenopausal patients with precision17

    RxPONDER premenopausal chart

    Premenopausal women with Recurrence Score result of 0-25 had a significant benefit in DRFI from the addition of chemotherapy to endocrine therapy (competing risk-adjusted HR 0.64, 95% CI 0.43-0.95, P=0.026). Consistent benefit of chemotherapy was observed for IDFS for subgroups of age, tumor size, Recurrence Score result, and number of positive lymph nodes. The 5-year absolute benefit of chemotherapy for distant recurrence was 2.4% (RS 0-13: 2.3%; RS 14-25: 2.8%).

    Clinical utility in neoadjuvant patients

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